Verification of the effects of test food intake on tongue coatings and halitosis

UMIN ID: UMIN000051184

Registered date:07/08/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2023/06/12
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of test food for 8 consecutive weeks
Intake of placebo for 8 consecutive weeks

Outcome(s)

• Primary Outcome: Halitosis Tongue coating score judgement Number of oral bacteria
• Secondary Outcome: Visual Analogue Scale

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 59years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects with heart, liver, and kidney diseases (including complications of other diseases) (2) Subjects with a history of cardiovascular disease (3) Subjects with diabetes (4) Subjects with diseases currently being treated (5) Subjects who are allergic to food and drugs (6) Subjects with anemia symptoms (7) Subjects who go to the hospital for some illness or are treated with drugs and Chinese medicine (temporary administration is possible) (8) Subjects currently undergoing treatment for dental caries and periodontal disease (9) Subjects with caries (C3 or higher) or severe periodontal disease (10) Subjects who are in the hospital or being treated with drugs or herbal medicine for any disease (can be used additionally) (11) Subjects who play intense sports and subjects who are on a diet (12) Subjects with extremely irregular eating habits (13) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (14) Subjects who drink more than 60 g of average daily pure alcohol (15) Subjects who smoke an average of 21 or more cigarettes per day (16) Subjects who are participating in or will participate in other clinical trials at the start of this study (17) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Related Information

• Primary Sponsor: Miura Clinic, Medical Corporation Kanonkai
• Source(s) of Monetary Support: Rilis Co., Ltd.